Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes

This study aims to compare the effectiveness of Dextenza vs standard of care prednisolone taper after cataract surgery in diabetic patients with regards to controlling post-op inflammation at post-op days 7, 14, and 30.

Study Overview

• Status: Withdrawn
• Conditions: Macula Edema; Cataract Diabetic
• Intervention / Treatment: Drug: Prednisolone Acetate 1% Oph Susp; Drug: Dextenza 0.4Mg Ophthalmic Insert

Detailed Description

The inflammation after cataract surgery is controlled at the investigators' institution by a taper of prednisolone acetate 1%, which consists of four drops daily for one week, followed by three drops daily for one week, then two drops daily for one week, then one drop daily for one week. Due to the frequency of drops needed after cataract surgery, compliance with the post-op regimen often wavers. This study aims to evaluate the efficacy of Dextenza, which has been shown to be better than placebo after cataract surgery (1), against prednisolone acetate taper. If shown to be as effective without compromising safety, it could be a very convenient alternative to prednisolone acetate taper. Furthermore, if Dextenza is shown to be as effective as prednisolone taper in diabetic patients, it could be logically generalized that it would be effective in patients without diabetes as well, as patients without diabetes (and with no confounding risk factors, such as a history of uveitis) are less prone to developing post-op macular edema. Risks are minimal for this FDA approved treatment and include iridocyclitis (10%); intraocular pressure increased (6%); visual acuity reduced (2%); cystoid macular edema (1%); corneal edema (1%); eye pain (1%) and conjunctival hyperemia (1%). These risks are comparable to prednisolone acetate.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients with diagnosed diabetes
• Patients must be undergoing cataract surgery in each eye
• Patients must have no worse than moderate nonproliferative diabetic retinopathy

Exclusion Criteria:

• Patients must not have any history of documented macular edema on OCT
• Patients must not have any macular edema on pre-op OCT
• Patients must not have any history of uveitis
• Patients must not have severe nonproliferative or proliferative diabetic retinopathy
• Patients with operative complications will be excluded from this study
• Patients with any active corneal disease, infectious or rheumatologic, will be excluded
• Patients must not be pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Prednisolone Arm; Standard post-cataract surgery therapy arm; acts as control in each patient.	Drug: Prednisolone Acetate 1% Oph Susp; Standard Prednisolone taper following cataract surgery, QID for one week, followed by TID for one week, BID for one week, and QDaily for one week, then stop.
Active Comparator: Dextenza Arm; Investigational arm to compare the effectiveness of the Dextenza insert to standard therapy.	Drug: Dextenza 0.4Mg Ophthalmic Insert; Dexamethasone inserted into lower punctum at the end of cataract surgery in order to control inflammation in the eye for the following 30 days after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optical Coherence Tomography (OCT)	The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of inflammation in the eye following cataract surgery when compared to prednisolone acetate 1%.	7 days
Optical Coherence Tomography (OCT)	The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of inflammation in the eye following cataract surgery when compared to prednisolone acetate 1%.	14 days
Optical Coherence Tomography (OCT)	The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of inflammation in the eye following cataract surgery when compared to prednisolone acetate 1%.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macular Edema	The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of macular edema in the eye on OCT imaging following cataract surgery when compared to prednisolone acetate 1%.	7 days
Macular Edema	The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of macular edema in the eye on OCT imaging following cataract surgery when compared to prednisolone acetate 1%.	14 days
Macular Edema	The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of macular edema in the eye on OCT imaging following cataract surgery when compared to prednisolone acetate 1%.	30 days

Collaborators and Investigators

• Sponsor: Baylor Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 27, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Prednisolone; Dextenza
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Capsule Opacification; Sulfur Compounds; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Benzene Derivatives; Sulfonic Acids; Sulfur Acids; Benzenesulfonates; Arylsulfonates; Arylsulfonic Acids; Calcium Dobesilate; prednisolone acetate
• Other Study ID Numbers: iRIS RB Number 021-167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No